An interventional study of Active tDCS and Cognitive training in Fetal Alcohol Spectrum Disorders, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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Among 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States — 9 open to participants now, 10 under way, none of them phase 3. Fetal Alcohol Spectrum Disorders · United States.
Among the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States, this one is the 25th largest by enrollment of the 33 interventional ones that give a count, is the only one that started in 2017, is one of 22 with no phase, and was the 17th registered.
65 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
Browse Fetal Alcohol Spectrum Disorders studies →9 of the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States are open now. Recruiting first, the newest first:
University of Virginia · Sites in United States
Ages 18–44 · Women only · Healthy volunteers
University of Rochester · Sites in United States
Ages 18–25
University of California, Los Angeles · Sites in United States
Ages 8–12
University of Rochester · Sites in United States
Ages 18+
University of Rochester · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Fetal Alcohol Spectrum Disorders studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 10 Years to 16 Years · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 1
First in 2001; this study’s year is marked. 1 started in 2017.
This study's enrollment of 44 is below the median of 74 across 57 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Median enrollment 95 across the 33 interventional studies, 751 across the 3 observational. Of the 26 that completed or were terminated, 10 (38%) have results posted.
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None of the 36 has an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,217 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 4 studies filed under Fetal Alcohol Spectrum Disorders — fewer than ten, so there is no comparison to draw.
5 of the studies in Fetal Alcohol Spectrum Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06847165University of California, Los AngelesTrigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure | 2026-12-29 |
| NCT06638463University of RochesterMy Health Coach App RCT | 2026-12-31 |
| NCT05960461University of RochesterFamilies Moving Forward (FMF) Connect Pro for Mental Health Providers | 2027-04-30 |
| NCT05456321University of MinnesotaCIFASD 5 tDCS and Cognitive Training | 2027-05-31 |
| NCT05108974Jeff WozniakCholine Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study | 2027-07-31 |
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Among the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal alcohol exposure (PAE).
Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).
Device: Active tDCS · Behavioral: Cognitive training
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).
Behavioral: Cognitive training · Device: Sham tDCS
Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)
BrainHQ Computerized cognitive training
Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
BrainHQ Learning Rate
Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance
Time frame: Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.
Change in D-KEFS Verbal Fluency - Letter
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Change in D-KEFS Verbal Fluency - Category
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Change in D-KEFS Trail-making - Numbers
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Change in D-KEFS Trail-making - Letters
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Change in D-KEFS Trail-making - Combined
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Delis Rating of Executive Functioning (D-REF)
The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.
Time frame: D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section
Change in Flanker Inhibitory Control and Attention Task
The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.
Time frame: NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)
| Milestone | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Started | 20 | 24 |
| Completed | 19 | 19 |
| Not completed | 1 | 5 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 3 |
Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance
| milliseconds | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| BrainHQ Learning Rate | 867.6 ± 244.1 | 861.7 ± 264.2 |
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
| score on a scale | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in D-KEFS Verbal Fluency - Letter | -0.11 ± 2.05 | -0.05 ± 1.68 |
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
| score on a scale | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in D-KEFS Verbal Fluency - Category | -3.68 ± 3.93 | -3.42 ± 3.37 |
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
| score on a scale | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in D-KEFS Trail-making - Numbers | 1.11 ± 3.2 | 1.37 ± 3.2 |
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
| score on a scale | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in D-KEFS Trail-making - Letters | 1.05 ± 3.29 | -2.95 ± 3.73 |
The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
| score on a scale | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in D-KEFS Trail-making - Combined | -1.16 ± 6.24 | -2.05 ± 6.18 |
The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.
| t-score | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Delis Rating of Executive Functioning (D-REF) | 70.1 ± 11.9 | 73.2 ± 9.5 |
The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.
| t-score | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| Change in Flanker Inhibitory Control and Attention Task | 2.05 ± 8.1 | 3.52 ± 8.92 |
Collected over 56 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Training and Active tDCS | 0/19 (0%) | 0/19 (0%) | 19/19 (100%) |
| Cognitive Training and Sham tDCS | 0/19 (0%) | 0/19 (0%) | 19/19 (100%) |
| Event | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS |
|---|---|---|
| SleepinessGeneral disorders | 12/19 | 12/19 |
| ItchinessSkin and subcutaneous tissue disorders | 8/19 | 10/19 |
| Scalp discomfortSkin and subcutaneous tissue disorders | 8/19 | 7/19 |
| Difficulty paying attentionGeneral disorders | 7/19 | 5/19 |
| TinglingSkin and subcutaneous tissue disorders | 6/19 | 6/19 |
| HeadacheGeneral disorders | 5/19 | 4/19 |
| ForgetfullnessGeneral disorders | 3/19 | 3/19 |
| Neck painMusculoskeletal and connective tissue disorders | 2/19 | 0/19 |
| Unusual feelings, attitudes, emotionsGeneral disorders | 2/19 | 2/19 |
| NauseaGastrointestinal disorders | 2/19 | 0/19 |
| Age, Categorical(Participants) | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS | Total |
|---|---|---|---|
| <=18 years | 19 | 19 | 38 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 12 | 10 | 22 |
| Race (NIH/OMB)(Participants) | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 2 | 2 | 4 |
| White | 9 | 11 | 20 |
| More than one race | 6 | 2 | 8 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
| Delis Rating of Executive Functioning (D-REF)(t-score) | Cognitive Training and Active tDCS | Cognitive Training and Sham tDCS | Total |
|---|---|---|---|
| Mean | 69.9 ± 9.0 | 76.3 ± 11.7 | 72.4 ± 10.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Jan 2020, 26 months.
Results were first posted in Feb 2021, 1 year after primary completion.
Of 28 interventional studies with no phase under Fetal Alcohol Spectrum Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 26 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Fetal Alcohol Spectrum Disorders →